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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033443
Receipt No. R000038136
Scientific Title Employment status of cervical cancer patient
Date of disclosure of the study information 2018/07/19
Last modified on 2019/03/02

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Basic information
Public title Employment status of cervical cancer patient
Acronym Employment status of cervical cancer patient
Scientific Title Employment status of cervical cancer patient
Scientific Title:Acronym Employment status of cervical cancer patient
Region
Japan

Condition
Condition cervical cancer
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Survey on the actual condition of employment status of cervical cancer patients
Basic objectives2 Others
Basic objectives -Others The relationship between employment status of cervical cancer and self-efficacy, self-esteem, dysfunction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Employment status of cervical cancer patient
Key secondary outcomes 1)The relationship between employment status of cervical cancer patient and self-efficacy
2) The relationship between employment status of cervical cancer patient and self-esteem
3) The relationship between employment status of cervical cancer patient and dysfunction

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria 1)Patient aged from 20 to 64
2)Patient who have undergone any of the following treatments for cervical cancer and have been 6 months to 5 years after the start of treatment
(1) Cervical malignant tumor surgery and Lymph node dissection (including enforcement of adjuvant therapy)
(2) Concurrent Chemoradiation Therapy(including enforcement of adjuvant therapy)
3) Patient who is judged by primary doctor
4) Patient who gained consent to participate in research
Key exclusion criteria 1) Patient who had a diagnosis of other cancers within 5 years
2) Patient with cognitive impairment or mental disorders
3) Patient with distant metastasis or recurrence
4) Patient who are undergoing treatment for cervical cancer
5) Those who cannot understand Japanese to complete the questionnaire
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Komatsu Hiroko
Organization Keio University Graduate School of Health Management
Division name Nursing
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL 03-5363-3733
Email komah@sfc.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Iijima Miho
Organization Keio University Graduate School of Health Management
Division name Nursing
Zip code
Address 4411 Endo, Fujisawa-shi, Kanagawa 252-0883 Japan
TEL 0466-49-6200
Homepage URL
Email h17701mg@sfc.keio.ac.jp

Sponsor
Institute Keio University Graduate School of Health Management
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学病院(東京都)
Keio University hospital(Tokyo)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: Observational cross-sectional study
Measures
1)Self-efficacy
2)Self-esteem
3)Dysfunction

Management information
Registered date
2018 Year 07 Month 19 Day
Last modified on
2019 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038136

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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